Friday Five - The pharma week in review (5 September 2019)

ESC round-up

A number of important questions were raised by new clinical data presented at the European Society of Cardiology (ESC) congress earlier this week.

Will AstraZeneca's SGLT-2 inhibitor Farxiga carve out additional use in non-diabetic heart failure patients? - The outlook is positive, according to cardiologists and key opinion leader feedback.

Physician Views snap poll results: Cardiologists enthused by AstraZeneca's Farxiga data in heart failure  

KOL Views Results: Competing HF readouts anoint AstraZeneca's Farxiga the big winner at ESC 

Experts also provided positive assessment of The Medicine Company's inclisiran, a potential competitor to PCSK9 inhibitors for the treatment of dyslipidaemia; see also Physician Views snap poll: Asking cardiologists to assess The Medicine Company's new data for inclisiran

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Vertex makes another big bet…

…this time in type 1 diabetes; the biotech is acquiring cell therapy specialist Semma Therapeutics for $950 million.

While diabetes is a new disease area for Vertex Pharmaceuticals (which has previously focused on hepatitis C, has revolutionised the treatment of cystic fibrosis and is also eying up future success in Duchenne muscular dystrophy), the deal should not be considered divergent, the company told FirstWord.

"It's really about the science and potential for transformative benefit in patients, as well we being able to fit into that 'specialty market' category, meaning we wouldn't have to build a large salesforce," a Vertex spokesperson said.

More on the deal and its impact on Vertex here.

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Novartis lines up Ocrevus competitor

Roche's Ocrevus has changed the treatment landscape in multiple sclerosis and its cross-town rival Novartis wants a piece of the pie. Novartis has confirmed its would-be competitor ofatumumab has met its primary and secondary endpoints in two pivotal-stage studies.

Full results will be presented at the ECTRIMS congress later this month; in the meantime, could a different dosing regimen prove advantageous for ofatumumab?

Neurologists agree that Novartis' approach certainly has its merits. If ofatumumab's Phase III results are comparable to Ocrevus, Roche could have competition on its hands.

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Previewing WCLC

The World Conference on Lung Cancer (WCLC) takes place on and around this weekend in Barcelona, Spain.

A key presentation will be data from AstraZeneca's CASPIAN study, evaluating its PD-L1 inhibitor Imfinzi plus chemotherapy in first-line small-cell lung cancer (SCLC). Roche's Tecentriq/chemotherapy combination set the bar that AstraZeneca will be looking to beat - a median overall survival benefit of two months - at last year's WCLC meeting.

Read our full WCLC preview here.

Expectations are also high ahead of updated results for Amgen's KRAS inhibitor AMG510 in non-small-cell lung cancer; see ViewPoints: What’s all the fuss about KRAS inhibitors?

Illustrating the growing level of interest in this previously considered 'un-druggable' target, Boehringer Ingelheim announced a deal this week to collaborate with Lupin on developing a KRAS/MEK inhibitor combination product.

Boehringer Ingelheim says it has a number of KRAS inhibitors in development.

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Amarin gets European Vascepa boost

Also announced this week was an update to ESC and European Atherosclerosis Society (EAS) guidelines for the management of dyslipidaemias to incorporate findings from Amarin’s REDUCE-IT study.

Analysts at Jefferies described the update as “an incremental positive surprise,” for Amarin which “should add confidence to future EMA approval [of Vascepa],” which is expected to occur next year. They model peak annual sales of $3 billion for the Omega-3 product, including billion dollar revenues in the EU.

Based on pre-approval, off-label use to lower residual cardiovascular risk in patients with statin-managed LDL cholesterol and persistent elevated triglycerides, Amarin recently upped its full year sales forecast for Vascepa: and with good reason -  Physician Views snap poll results: Prescriber feedback supports Amarin's bullish projections for Vascepa.

However, confirmation that the FDA plans to convene an advisory committee meeting to discuss expanding Vascepa’s label in the US market has prompted some concern among Amarin shareholders. The company has faced scrutiny for using mineral oil in the REDUCE-IT control arm, though physicians polled by FirstWord and key opinion leaders have played down the overall impact of this. It remains to be seen if the FDA’s main line of questioning focuses on this topic.

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